Skip to main content
OpenTrials
Completed

NCT Number: NCT02998814

Clinical Follow Up of a Fissure Sealant Placed With Different Adhesive Protocols: 2-Year Randomized Split Mouth Study

The purpose of this study was to evaluate the retention rates of a fissure sealant placed using different adhesive protocols over 24 months.Twenty-four subjects with no restoration and caries received fissure sealants (Clinpro™Sealant, 3M/ESPE) placed with different adhesive protocols. A total of 292 sealants (73 for each group) were placed. The sealants were placed as follows; a-without adhesive (acid-etch only), b-with an etch-and-rinse adhesive (SingleBondTM), c-with a self-etch adhesive (AdperTMEasyBond), d-with acid-etch+self-etch adhesive (AdperTMEasyBond) by two previously calibrated dentists using a table of random numbers. Two other calibrated examiners, independently evaluated the sealants at baseline and at 6-, 12-, 18-, and 24-month recalls. Each sealant was evaluated in terms of caries formation being present or absent and retention using the following criteria: 1=completely retained, 2=partial loss, and 3=total loss. The Pearson χ2 test was used to evaluate differences in retention rates among the sealants for each evaluation period.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fissure Sealant Loss Caries

Age range

20 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

Dental caries, which can be encountered by individuals throughout their lives, is one of the most chronic diseases worldwide. Researches have mainly been focusing on the prevention of tooth caries with the awareness of this fact. The use of fluorides as well as pit-and-fissure sealants are the most common preventive applications against caries progression.Modern adhesives combine conventional conditioning, priming and bonding steps (etch-and-rinse adhesives) together into one or two bottle (self-etch adhesives) to ease adhesive protocols. However, it is still suspicious whether modern self-etch adhesives have equal bonding capacity to the conventional etch-and-rinse systems. Therefore, clinical trials are necessary to evaluate long-term adhesive performance of self-etch adhesives compared to the conventional etch-and-rinse ones.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who participated in the current study had good general and oral health and hygiene.
  • with no detecatable caries, bruxism, malocclusion, previously placed restorations or sealants on the fissures, or no allergies to resins
  • willing to return for follow-up examinations

Exclusion criteria

  • Third molars
  • Uncooperative patients
  • Molar teeth with antagonist tooth not present or extracted
  • Mentally and physically handicapped patients

Treatment and study plan

acid-etch

Other

acid-etch

self-etch adhesive

Other

Self etch (7th generation ) bonding agent

Other names: Adper Easy bond 3M ESPE

etch-and-rinse adhesive

Other

Total etch bonding agent (5th generation)

Other names: Single BondTM, 3M ESPE

self-etch adhesive after acid-etch

Other

acid etch + self-etch adhesive Self etch (7th generation ) bonding agent

Other names: acid etch + self-etch adhesive

Primary outcomes

  1. Changes in retention of sealants from baseline to two years

    Time frame: at baseline and at 6-, 12-, 18-, and 24-month

    The assessment of the retention of sealants (intact, partially lost, completely lost) will be carried out every 6 month for 2 years.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Split Mouth Clinical Trial of Fissure Sealant Retention With Self Etching and Total Etch Bonding Agent

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Dec 20, 2016
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.